FDA 510(k)

Niti-S Esophageal Stent; Esophageal TTS Stent

K-Number: K243619 · 2025-10-30

Decision Date2025-10-30

Product CodeESW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Niti-S Esophageal Stent; Esophageal TTS Stent is the device name listed in this FDA 510(k) record. The listed applicant is Taewoong Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-10-30 under 510(k) number K243619. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Niti-S Esophageal Stent; Esophageal TTS Stent?

Niti-S Esophageal Stent; Esophageal TTS Stent is a medical device that received FDA 510(k) clearance on 2025-10-30. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K243619.

When did Niti-S Esophageal Stent; Esophageal TTS Stent receive FDA 510(k) clearance?

Niti-S Esophageal Stent; Esophageal TTS Stent received FDA 510(k) clearance on 2025-10-30, under 510(k) number K243619.

Who is the listed applicant for Niti-S Esophageal Stent; Esophageal TTS Stent?

The FDA 510(k) record lists Taewoong Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Niti-S Esophageal Stent; Esophageal TTS Stent?

The FDA product code for Niti-S Esophageal Stent; Esophageal TTS Stent is ESW.

Other records listing Taewoong Medical Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260962Sphincterotome K252648Niti-S SPAXUS Stent K251123Niti-S Biliary Stent; Niti-S Biliary Slim M Stent K250663Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent K240522Esophageal TTS Stent K223067Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent

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Related Devices (Code: ESW)

K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.K251265Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc.K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific K233837Agile Esophageal Stent SystemBoston Scientific Corporation K240522Esophageal TTS StentTaewoong Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.